Advancements in Impurity Profiling of Pharmaceuticals: A Comprehensive Review

Abstract

Impurity profiling is a crucial aspect of pharmaceutical analysis, aimed at ensuring the safety, efficacy, and quality of drug products. The presence of impurities, even at trace levels, can significantly impact the pharmacological properties of pharmaceuticals, posing risks to patient health. This review provides an in-depth examination of impurity profiling methodologies, recent advancements, challenges, and future perspectives in the field. Various analytical techniques, including chromatography, spectroscopy, and mass spectrometry, are discussed, along with regulatory requirements and industry practices. Furthermore, emerging trends such as the application of artificial intelligence and automation in impurity profiling are explored, highlighting their potential to revolutionize pharmaceutical analysis.